A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001
Trial Information
Current as of July 01, 2025
Completed
Keywords
ClinConnect Summary
In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:
Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Patients must have:
- • Documented HIV-1 seropositive status.
- • CD4 count greater than 100 cells/mm3.
- • Parental consent for patients under 18.
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Chicago, Illinois, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Akron, Ohio, United States
San Francisco, California, United States
New York, New York, United States
Boston, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Sacramento, California, United States
Albany, New York, United States
Birmingham, Alabama, United States
Los Angeles, California, United States
Los Angeles, California, United States
Fort Lauderdale, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Bethesda, Maryland, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
Camden, New Jersey, United States
Voorhees, New Jersey, United States
Brooklyn, New York, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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